MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER CARE TRAY

Model Number URO170814

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Foley catheter inserted.When balloon filled, the sterile water syringe tip broke in the catheter.

• Brand Name: MEDLINE
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 16918421
• MDR Text Key: 315086879
• Report Number: 16918421
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: URO170814
• Device Catalogue Number: URO170814
• Device Lot Number: 23ABT569
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2023
• Date Report to Manufacturer: 05/12/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female